EP3656377C0 - Wässrige formulierung mit paracetamol und ibuprofen - Google Patents

Wässrige formulierung mit paracetamol und ibuprofen

Info

Publication number: EP3656377C0
Authority: EP; European Patent Office
Prior art keywords: paracetamol; ibuprofen; aqueous formula; aqueous; formula
Prior art date: 2014-07-18
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Active

Application number

EP19215735.2A

Other languages

English (en)

French (fr)

Other versions

EP3656377B1 (de

EP3656377A1 (de

Inventor

Thomas Jacobsen

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Hyloris Pharmaceuticals SA

Original Assignee

Hyloris Pharmaceuticals SA

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2014-07-18

Filing date

2015-07-17

Publication date

2025-02-12

2015-07-17 Application filed by Hyloris Pharmaceuticals SA filed Critical Hyloris Pharmaceuticals SA

2020-05-27 Publication of EP3656377A1 publication Critical patent/EP3656377A1/de

2025-02-12 Application granted granted Critical

2025-02-12 Publication of EP3656377C0 publication Critical patent/EP3656377C0/de

2025-02-12 Publication of EP3656377B1 publication Critical patent/EP3656377B1/de

Status Active legal-status Critical Current

2035-07-17 Anticipated expiration legal-status Critical

Links

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/1407—Infusion of two or more substances
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical & Material Sciences (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Pharmacology & Pharmacy (AREA)
Medicinal Chemistry (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Hematology (AREA)
Oil, Petroleum & Natural Gas (AREA)
Organic Chemistry (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Pain & Pain Management (AREA)
Biomedical Technology (AREA)
Heart & Thoracic Surgery (AREA)
Vascular Medicine (AREA)
Anesthesiology (AREA)
Rheumatology (AREA)
Bioinformatics & Cheminformatics (AREA)
Dermatology (AREA)
Molecular Biology (AREA)
Biochemistry (AREA)
Orthopedic Medicine & Surgery (AREA)
Immunology (AREA)
Physical Education & Sports Medicine (AREA)
Endocrinology (AREA)
Reproductive Health (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Medicinal Preparation (AREA)
Proteomics, Peptides & Aminoacids (AREA)

EP19215735.2A 2014-07-18 2015-07-17 Wässrige formulierung mit paracetamol und ibuprofen Active EP3656377B1 (de)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
PCT/EP2014/065544 WO2016008546A1 (en)	2014-07-18	2014-07-18	Aqueous formulation comprising paracetamol and ibuprofen
EP15738918.0A EP3169307B1 (de)	2014-07-18	2015-07-17	Wässrige formulierung mit paracetamol und ibuprofen
PCT/EP2015/066466 WO2016009067A1 (en)	2014-07-18	2015-07-17	Aqueous formulation comprising paracetamol and ibuprofen

Related Parent Applications (2)

Application Number	Title	Priority Date	Filing Date
EP15738918.0A Division EP3169307B1 (de)	2014-07-18	2015-07-17	Wässrige formulierung mit paracetamol und ibuprofen
EP15738918.0A Division-Into EP3169307B1 (de)	2014-07-18	2015-07-17	Wässrige formulierung mit paracetamol und ibuprofen

Publications (3)

Publication Number	Publication Date
EP3656377A1 EP3656377A1 (de)	2020-05-27
EP3656377C0 true EP3656377C0 (de)	2025-02-12
EP3656377B1 EP3656377B1 (de)	2025-02-12

Family

ID=51211244

Family Applications (2)

Application Number	Title	Priority Date	Filing Date
EP15738918.0A Active EP3169307B1 (de)	2014-07-18	2015-07-17	Wässrige formulierung mit paracetamol und ibuprofen
EP19215735.2A Active EP3656377B1 (de)	2014-07-18	2015-07-17	Wässrige formulierung mit paracetamol und ibuprofen

Family Applications Before (1)

Application Number	Title	Priority Date	Filing Date
EP15738918.0A Active EP3169307B1 (de)	2014-07-18	2015-07-17	Wässrige formulierung mit paracetamol und ibuprofen

Country Status (26)

Country	Link
US (5)	US11219609B2 (de)
EP (2)	EP3169307B1 (de)
JP (2)	JP6745798B2 (de)
CN (2)	CN106794163B (de)
AR (1)	AR100365A1 (de)
AU (1)	AU2015289035B2 (de)
BR (1)	BR112017001093B1 (de)
CA (1)	CA2955557C (de)
CY (1)	CY1122899T1 (de)
DK (1)	DK3169307T3 (de)
EA (1)	EA036212B1 (de)
ES (2)	ES2791349T3 (de)
HR (1)	HRP20200704T1 (de)
HU (1)	HUE048881T2 (de)
IL (1)	IL250112B2 (de)
LT (1)	LT3169307T (de)
MX (1)	MX381776B (de)
MY (1)	MY192813A (de)
NZ (1)	NZ728796A (de)
PL (2)	PL3656377T3 (de)
PT (1)	PT3169307T (de)
RS (1)	RS60289B1 (de)
SG (1)	SG11201700421RA (de)
SI (1)	SI3169307T1 (de)
TN (1)	TN2017000011A1 (de)
WO (2)	WO2016008546A1 (de)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2016008546A1 (en)	2014-07-18	2016-01-21	Everbright Pharmaceuticals S.A.R.L.	Aqueous formulation comprising paracetamol and ibuprofen
JP7386080B2 (ja) *	2016-08-02	2023-11-24	アンバーアイピーリミテッド	安定なイブプロフェン注射製剤用組成物
DE102017202510A1 (de)	2017-02-16	2018-08-16	Eurozyto Gmbh	Behältnis zur Bereitstellung patientenspezifischer Arzneimittel
WO2018192664A1 (en)	2017-04-20	2018-10-25	Hyloris Developments Sa	METHOD FOR PREPARING A COMPOSITION WITH A LOW DISSOLVED OXYGEN CONTENT, COMPRISING ACETAMINOPHEN, AND OPTIONALLY ONE OR MORE NSAIDs, AND A COMPOSITION OBTAINED THEREOF
WO2022178018A1 (en) *	2021-02-19	2022-08-25	Nevakar Injectables Inc.	Liquid unit dosage forms for treatment of pain
CN117241790A (zh) *	2021-04-28	2023-12-15	葛兰素史克消费保健（美国）控股有限责任公司	不相容活性药物成分的碱金属盐组合
CN114062554B (zh) *	2021-11-20	2023-07-21	山东百诺医药股份有限公司	一种同时测定对乙酰氨基酚布洛芬有关物质的分析方法
IL324832A (en)	2023-06-02	2026-01-01	Ioulia Tseti	Pharmaceutical composition comprising ibuprofen
GR1010809B (el) *	2023-09-13	2024-10-25	Ιουλια Τσετη	Υδατικο διαλυμα ιβουπροφαινης παρακεταμολης για χρηση σε ενδοφλεβια χορηγηση
GR1010769B (el) *	2023-07-27	2024-09-18	Ιουλια Κλεωνος Τσετη	Υδατικο διαλυμα ιβουπροφαινης για χρηση σε ενδοφλεβια χορηγηση
GR1011104B (el) *	2024-12-18	2026-01-16	Ιουλια Τσετη	Προγεμισμενη συριγγα υδατικου διαλυματος παρακεταμολης καταλληλη για ενεσιμη χορηγηση

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
FR2809619B1 (fr) *	2000-06-06	2004-09-24	Pharmatop	Nouvelles formulations aqueuses de principes actifs sensibles a l'oxydation et leur procede d'obtention
US20060100578A1 (en) *	2004-09-13	2006-05-11	Tandem Medical, Inc.	Medication delivery apparatus and methods for intravenous infusions
JP2011508768A (ja) *	2008-01-03	2011-03-17	ウォックハートリサーチセンター	パラセタモール及びイブプロフェンを含む医薬用経口懸濁剤
US20110166234A1 (en)	2008-10-14	2011-07-07	Atkinson Hartley Campbell	Medicinal product and treatment
EP2243477A1 (de)	2009-04-22	2010-10-27	Fresenius Kabi Deutschland GmbH	Paracetamol zur parenteralen Verabreichung
US8404748B2 (en) *	2009-08-13	2013-03-26	Neogen N.V.	Storage-stable formulation of paracetamol in aqueous solution
DK2389923T3 (da) *	2010-05-19	2013-03-18	Uni Pharma Kleon Tsetis Pharmaceutical Lab S A	Stabil klar til brug injicerbar paracetamol-formulering
US20130225685A1 (en) *	2010-11-04	2013-08-29	Aft Pharmaceuticals Limited	Combination composition
BE1020614A5 (nl)	2012-01-27	2014-01-07	Hubert De Backer Nv	Injectiespuit.
WO2013138628A2 (en) *	2012-03-16	2013-09-19	Cumberland Pharmaceuticals, Inc.	Injectable ibuprofen formulation
US9072661B2 (en) *	2012-03-16	2015-07-07	Cumberland Pharmaceuticals Inc.	Injectable ibuprofen formulation
WO2016008546A1 (en)	2014-07-18	2016-01-21	Everbright Pharmaceuticals S.A.R.L.	Aqueous formulation comprising paracetamol and ibuprofen
WO2018192664A1 (en)	2017-04-20	2018-10-25	Hyloris Developments Sa	METHOD FOR PREPARING A COMPOSITION WITH A LOW DISSOLVED OXYGEN CONTENT, COMPRISING ACETAMINOPHEN, AND OPTIONALLY ONE OR MORE NSAIDs, AND A COMPOSITION OBTAINED THEREOF

2014
- 2014-07-18 WO PCT/EP2014/065544 patent/WO2016008546A1/en not_active Ceased
2015
- 2015-05-11 AR ARP150101427A patent/AR100365A1/es not_active Application Discontinuation
- 2015-07-17 CA CA2955557A patent/CA2955557C/en active Active
- 2015-07-17 PT PT157389180T patent/PT3169307T/pt unknown
- 2015-07-17 PL PL19215735.2T patent/PL3656377T3/pl unknown
- 2015-07-17 HU HUE15738918A patent/HUE048881T2/hu unknown
- 2015-07-17 CN CN201580048136.2A patent/CN106794163B/zh active Active
- 2015-07-17 BR BR112017001093-3A patent/BR112017001093B1/pt active IP Right Grant
- 2015-07-17 PL PL15738918T patent/PL3169307T3/pl unknown
- 2015-07-17 TN TN2017000011A patent/TN2017000011A1/en unknown
- 2015-07-17 SG SG11201700421RA patent/SG11201700421RA/en unknown
- 2015-07-17 JP JP2017522738A patent/JP6745798B2/ja active Active
- 2015-07-17 DK DK15738918.0T patent/DK3169307T3/da active
- 2015-07-17 LT LTEP15738918.0T patent/LT3169307T/lt unknown
- 2015-07-17 ES ES15738918T patent/ES2791349T3/es active Active
- 2015-07-17 EP EP15738918.0A patent/EP3169307B1/de active Active
- 2015-07-17 HR HRP20200704TT patent/HRP20200704T1/hr unknown
- 2015-07-17 RS RS20200513A patent/RS60289B1/sr unknown
- 2015-07-17 US US15/326,958 patent/US11219609B2/en active Active
- 2015-07-17 MY MYPI2017000076A patent/MY192813A/en unknown
- 2015-07-17 EA EA201790223A patent/EA036212B1/ru unknown
- 2015-07-17 MX MX2017000764A patent/MX381776B/es unknown
- 2015-07-17 NZ NZ728796A patent/NZ728796A/en unknown
- 2015-07-17 ES ES19215735T patent/ES3013411T3/es active Active
- 2015-07-17 EP EP19215735.2A patent/EP3656377B1/de active Active
- 2015-07-17 WO PCT/EP2015/066466 patent/WO2016009067A1/en not_active Ceased
- 2015-07-17 SI SI201531187T patent/SI3169307T1/sl unknown
- 2015-07-17 CN CN202110260116.9A patent/CN113018258A/zh active Pending
- 2015-07-17 IL IL250112A patent/IL250112B2/en unknown
- 2015-07-17 AU AU2015289035A patent/AU2015289035B2/en active Active
2019
- 2019-05-28 US US16/424,274 patent/US11213498B2/en active Active
- 2019-12-13 JP JP2019225921A patent/JP6892494B2/ja active Active
2020
- 2020-05-12 CY CY20201100433T patent/CY1122899T1/el unknown
2021
- 2021-10-15 US US17/502,899 patent/US11389416B2/en active Active
2022
- 2022-07-18 US US17/867,370 patent/US12083087B2/en active Active
2024
- 2024-09-09 US US18/827,922 patent/US20250064764A1/en active Pending

Also Published As

Publication number	Publication date
CN113018258A (zh)	2021-06-25
IL250112A0 (en)	2017-03-30
MY192813A (en)	2022-09-09
SI3169307T1 (sl)	2020-07-31
CN106794163B (zh)	2021-03-26
HRP20200704T1 (hr)	2020-07-24
AU2015289035B2 (en)	2020-03-26
AU2015289035A1 (en)	2017-02-23
MX2017000764A (es)	2017-08-18
IL250112B (en)	2022-10-01
NZ728796A (en)	2023-05-26
ES3013411T3 (en)	2025-04-11
EA036212B1 (ru)	2020-10-14
EA201790223A1 (ru)	2017-05-31
PL3656377T3 (pl)	2025-05-26
AR100365A1 (es)	2016-09-28
CA2955557A1 (en)	2016-01-21
US20230181502A1 (en)	2023-06-15
BR112017001093B1 (pt)	2023-01-31
EP3656377B1 (de)	2025-02-12
US20250064764A1 (en)	2025-02-27
WO2016008546A1 (en)	2016-01-21
US11389416B2 (en)	2022-07-19
TN2017000011A1 (en)	2018-07-04
WO2016009067A1 (en)	2016-01-21
CY1122899T1 (el)	2021-05-05
SG11201700421RA (en)	2017-02-27
LT3169307T (lt)	2020-07-10
ES2791349T3 (es)	2020-11-04
US20220031645A1 (en)	2022-02-03
PT3169307T (pt)	2020-05-18
BR112017001093A2 (pt)	2017-11-14
JP6745798B2 (ja)	2020-08-26
US12083087B2 (en)	2024-09-10
RS60289B1 (sr)	2020-07-31
JP2017522382A (ja)	2017-08-10
US11213498B2 (en)	2022-01-04
PL3169307T3 (pl)	2020-09-21
JP2020059740A (ja)	2020-04-16
US11219609B2 (en)	2022-01-11
CA2955557C (en)	2021-06-22
EP3656377A1 (de)	2020-05-27
US20190343785A1 (en)	2019-11-14
CN106794163A (zh)	2017-05-31
US20170209398A1 (en)	2017-07-27
MX381776B (es)	2025-03-13
IL250112B2 (en)	2023-02-01
DK3169307T3 (da)	2020-05-11
HUE048881T2 (hu)	2020-08-28
EP3169307A1 (de)	2017-05-24
EP3169307B1 (de)	2020-02-19
JP6892494B2 (ja)	2021-06-23

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